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Table 2 Decision-related outcomes at baseline (t0), three (t1) and six months (t2) after study inclusion

From: Effectiveness of evidence-based decision aids for women with pathogenic BRCA1 or BRCA2 variants in the german health care context: results from a randomized controlled trial

  

TG

 

IG

 

CG

 

t0: baseline

Instrument / Score

n

mean (SD)

range

 

n

mean (SD)

range

 

n

mean (SD)

range

p-value

Decisional conflict

DCS informed

415

30.9 (21.4)

0-100

 

216

31.6 (22.0)

0-100

 

199

30.2 (20.7)

0-91.7

0.624

DCS values clarity

412

35.6 (24.6)

0-100

 

213

36.1 (24.4)

0-100

 

199

35.0 (25.0)

0-100

0.620

DCS support

414

27.2 (19.4)

0-83.3

 

215

27.0 (20.1)

0-83.3

 

199

27.4 (18.7)

0-83.3

0.831

DCS uncertainty

413

49.6 (28.8)

0-100

 

216

50.2 (29.2)

0-100

 

197

48.9 (28.4)

0-100

0.630

DCS effective decision

409

36.1 (26.4)

0-100

 

214

37.7 (26.9)

0-100

 

195

34.2 (25.8)

0-100

0.170

DCS total

396

36.0 (20.8)

0-95.3

 

211

36.8 (21.3)

0-95.3

 

185

35.0 (20.2)

0-87.5

0.383

  

n

%

  

n

%

  

n

%

  

Decision status

SDM-S undecided

223

53.5

  

115

53.2

  

108

53.7

 

0.920

SDM-S decided, of these

194

46.5

  

101

46.8

  

93

46.3

 

0.920

IBS/IBSA only

20

4.8

  

14

6.5

  

6

3

 

0.095

RRM only

11

2.6

  

6

2.8

  

5

2.5

 

0.853

IBS/IBSA plus RRBSO

100

24.0

  

44

20.4

  

56

27.9

 

0.073

RRM plus RRBSO

63

15.1

  

37

17.1

  

26

12.9

 

0.232

t1: after 3 months

Instrument / Score

n

mean (SD)

range

 

n

mean (SD)

range

 

n

mean (SD)

range

p-value

Decisional conflict

DCS informed

391

23.6 (20.3)

0-83.3

 

200

20.4 (19.6)

0-83.3

 

191

27.0 (20.5)

0-83.3

0.001

DCS values clarity

392

28.0 (23.5)

0-100

 

201

25.8 (22.5)

0-91.7

 

191

30.2 (24.4)

0-100

0.082

DCS support

391

24.3 (20.7)

0-100

 

202

21.5 (20.2)

0-83.3

 

189

27.2 (20.8)

0-100

0.003

DCS uncertainty

394

40.6 (28.7)

0-100

 

202

39.8 (28.1)

0-100

 

192

41.5 (29.3)

0-100

0.617

DCS effective decision

383

28.7 (23.8)

0-100

 

195

28.1 (22.8)

0-100

 

188

29.3 (24.9)

0-100

0.806

DCS total

375

28.6 (20.4)

0-87.5

 

193

26.7 (19.3)

0-76.6

 

182

30.6 (21.3)

0-87.5

0.049#

  

n

%

  

n

%

  

n

%

  

Decision status

SDM-S undecided

150

38.3

  

75

37.3

  

75

39.3

 

0.691

SDM-S decided, of these

242

61.7

  

126

62.7

  

116

60.7

 

0.691

IBS/IBSA only

22

5.6

  

14

7.0

  

8

4.2

 

0.233

RRM only

14

3.6

  

6

3.0

  

8

4.2

 

0.521

IBS/IBSA plus RRBSO

94

24.0

  

40

19.9

  

54

28.3

 

0.052

RRM plus RRBSO

112

28.6

  

66

32.8

  

46

24.1

 

0.055

t2: after 6 months

Instrument / Score

n

mean (SD)

range

 

n

mean (SD)

range

 

n

mean (SD)

range

p-value

Decisional conflict

DCS informed

382

22.4 (19.0)

0-83.3

 

193

18.5 (17.3)

0–75

 

189

26.4 (19.8)

0-83.3

0.000

DCS values clarity

380

24.8 (22.7)

0-91.7

 

193

21.8 (21.2)

0-91.7

 

187

27.9 (23.8)

0-91.7

0.011

DCS support

381

22.2 (19.3)

0-83.3

 

192

19.1 (18.2)

0–75

 

189

25.4 (20.0)

0-83.3

0.002

DCS uncertainty

381

36.5 (27.8)

0-100

 

193

34.8 (27.3)

0-100

 

188

38.2 (28.2)

0-100

0.249

DCS effective decision

377

25.9 (23.2)

0-100

 

191

23.8 (22.3)

0-100

 

186

28.1 (24.0)

0-100

0.071

DCS total

373

26.4 (19.9)

0-81.3

 

190

23.5 (18.7)

0-78.1

 

183

29.4 (20.6)

0-81.3

0.006

Decision regret

DRS IBS/IBSA

317

9.2 (13.1)

0–55

 

158

9.2 (13.1)

0–45

 

159

9.1 (13.0)

0–55

0.934

DRS RRM

101

10.6 (13.7)

0–50

 

57

11.5 (13.2)

0–45

 

44

9.5 (14.4)

0–50

0.482

DRS RRBSO

204

9.5 (12.1)

0–55

 

97

9.6 (12.0)

0–45

 

107

9.4 (12.2)

0–55

0.906

  

n

%

  

n

%

  

n

%

  

Decision status

SDM-S undecided

109

28.5

  

51

26.2

  

58

31.0

 

0.293

SDM-S decided, of these

273

71.5

  

144

73.8

  

129

69.0

 

0.293

IBS/IBSA only

23

6.0

  

12

6.2

  

11

5.9

 

0.911

RRM only

13

3.4

  

8

4.1

  

5

2.7

 

0.441

IBS/IBSA plus RRBSO

106

27.7

  

46

23.6

  

60

32.1

 

0.064

RRM plus RRBSO

131

34.3

  

78

40.0

  

53

28.3

 

0.016

  1. Statistical significance for any score: 2-sided Mann-Whitney-U-Test; except #: 1-sided according to study protocol [18]. Statistical significance for categorical variables: Pearson’s chi-quadrat-test. DCS: decisional conflict scale; SDM-S: stage of decision-making scale; DRS: decision regret scale; IBS/IBSA: intensified breast surveillance (and aftercare); RRM: risk-reducing mastectomy; RRBSO: risk-reducing bilateral salpingo-oophorectomy. TG: total group (IG and CG); IG: intervention group; CG: control group